{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T16:45:26Z","timestamp":1793724326788,"version":"4.6.1"},"reference-count":40,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"19","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,7,1]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a plasma-stable, selectively cleavable linker.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>TROPION-PanTumor01 (ClinicalTrials.gov identifier: NCT03401385 ) is a phase I, dose-escalation, and dose-expansion study evaluating Dato-DXd in patients with previously treated solid tumors. The primary study objective was to assess the safety and tolerability of Dato-DXd. Secondary objectives included evaluation of antitumor activity and pharmacokinetics. Results from patients with advanced\/metastatic hormone receptor\u2013positive\/human epidermal growth factor receptor 2\u2013negative (HR+\/HER2\u2013) breast cancer (BC) or triple-negative BC (TNBC) are reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>At data cutoff (July 22, 2022), 85 patients (HR+\/HER2\u2013 BC = 41, and TNBC = 44) had received Dato-DXd. The objective response rate by blinded independent central review was 26.8% (95% CI, 14.2 to 42.9) and 31.8% (95% CI, 18.6 to 47.6) for patients with HR+\/HER2\u2013 BC and TNBC, respectively. The median duration of response was not evaluable in the HR+\/HER2\u2013 BC cohort and 16.8 months in the TNBC cohort. The median progression-free survival in patients with HR+\/HER2\u2013 BC and TNBC was 8.3 and 4.4 months, respectively. All-cause treatment-emergent adverse events (TEAEs; any grade, grade \u22653) were observed in 100% and 41.5% of patients with HR+\/HER2\u2013 BC and 100% and 52.3% of patients with TNBC. Stomatitis was the most common TEAE (any grade, grade \u22653) in both HR+\/HER2\u2013 BC (82.9%, 9.8%) and TNBC (72.7%, 11.4%) cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>In patients with heavily pretreated advanced HR+\/HER2\u2013 BC and TNBC, Dato-DXd demonstrated promising clinical activity and a manageable safety profile. Dato-DXd is currently being evaluated in phase III studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.23.01909","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T16:02:21Z","timestamp":1713888141000},"page":"2281-2294","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":168,"title":["Datopotamab Deruxtecan in Advanced or Metastatic HR+\/HER2\u2013 and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct03401385","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4885-1157","authenticated-orcid":false,"given":"Aditya","family":"Bardia","sequence":"first","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, 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